VIZIMPRO FILM-COATED TABLET 15MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dacomitinib monohydrate eqv Dacomitinib

Available from:

PFIZER PRIVATE LIMITED

ATC code:

L01XE47

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Dacomitinib monohydrate eqv Dacomitinib 15 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

2020-06-25

Patient Information leaflet

VIZIMPRO
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PACKAGE INFORMATION LEAFLET
Page 1 of 18
VIZIMPRO FILM-COATED TABLETS
Dacomitinib
1.
NAME OF THE MEDICINAL PRODUCT
VIZIMPRO 15 mg film-coated tablets
VIZIMPRO 30 mg film-coated tablets
VIZIMPRO 45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dacomitinib monohydrate is a kinase inhibitor with a molecular formula
of
C
24
H
25
ClFN
5
O
2
·H
2
O and a molecular weight of 487.95 Daltons (or 469.94 Daltons as
dacomitinib anhydrate). The chemical structure of dacomitinib
monohydrate is:
_ _
Dacomitinib is a white to pale yellow powder with pKa values of 5.0
and 8.5.
Each film-coated tablet contains dacomitinib monohydrate equivalent to
15 mg or 30 mg or
45 mg of dacomitinib. For the full list of excipients, see Section 6.1
List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
VIZIMPRO 15 mg film-coated tablets
Tablet size of 6.35 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 15’ on the opposite
side.
VIZIMPRO 30 mg film-coated tablets
Tablet size of 7.5 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 30’ on the opposite
side.
VIZIMPRO 45 mg film-coated tablets
Tablet size of 9.0 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 45’ on the opposite
side.
Page 2 of 18
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
VIZIMPRO is indicated for the first-line treatment of patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with epidermal growth
factor receptor
(EGFR)-activating mutations (exon 19 deletion or exon 21 L858R
substitution mutations).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
EGFR mutation status should be established prior to initiation of
VIZIMPRO therapy.
Posology
The recommended dose of VIZIMPRO is 45 mg taken orally once daily,
until disease
progression or unacceptable toxicity occurs. VIZIMPRO can be taken
with or without food.
Patients should be encouraged to take their dos

Summary of Product characteristics

VIZIMPRO
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 18
VIZIMPRO FILM-COATED TABLETS
Dacomitinib
1. NAME OF THE MEDICINAL PRODUCT
VIZIMPRO 15 mg film-coated tablets
VIZIMPRO 30 mg film-coated tablets
VIZIMPRO 45 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dacomitinib monohydrate is a kinase inhibitor with a molecular formula
of
C
24
H
25
ClFN
5
O
2
·H
2
O and a molecular weight of 487.95 Daltons (or 469.94 Daltons as
dacomitinib anhydrate). The chemical structure of dacomitinib
monohydrate is:
Dacomitinib is a white to pale yellow powder with pKa values of 5.0
and 8.5.
Each film-coated tablet contains dacomitinib monohydrate equivalent to
15 mg or 30 mg or
45 mg of dacomitinib. For the full list of excipients, see Section 6.1
List of excipients.
3. PHARMACEUTICAL FORM
Film-coated tablets.
VIZIMPRO 15 mg film-coated tablets
Tablet size of 6.35 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 15’ on the opposite
side.
VIZIMPRO 30 mg film-coated tablets
Tablet size of 7.5 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 30’ on the opposite
side.
VIZIMPRO 45 mg film-coated tablets
Tablet size of 9.0 mm with de-bossing of ‘Pfizer’ on one side and
‘DCB 45’ on the opposite
side.
Page 2 of 18
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
VIZIMPRO is indicated for the first-line treatment of patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with epidermal growth
factor receptor
(EGFR)-activating mutations (exon 19 deletion or exon 21 L858R
substitution mutations).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
EGFR mutation status should be established prior to initiation of
VIZIMPRO therapy.
Posology
The recommended dose of VIZIMPRO is 45 mg taken orally once daily,
until disease
progression or unacceptable toxicity occurs. VIZIMPRO can be taken
with or without food.
Patients should be encouraged to take their dose at